CompletedNot Applicable

Symptoms Based Awareness Confirmation Study - CoMiSS Validation

China300 participantsStarted 2016-12

Plain-language summary

The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children. Many infants and toddlers with symptoms that can be related to intake of cow's milk and cow's milk protein allergy (CMPA) are often not diagnosed due to the lack of specific markers. The goal of this trial is to validate the CoMiSS tool in infants suspected of CMPA and investigate if the CoMiSS tool could be an alternative to the open challenge test needed to confirm the diagnosis of Cow Milk Protein Allergy.

Who can participate

Age range

1 Day – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female infant aged up to 6 months old * Has been fed exclusively on cow's milk infant formula for at least one week * Has CMPA symptoms that have been present for at least one week, and that developed within the first two months of starting cow's milk infant formula * In the opinion of the investigator, requires a two week elimination diet with Amino Acid Formula (AAF). * Had a gestational age at birth of 37 to 42 weeks * Had a birthweight of 2500 g to 4500 g * Informed consent signed by both parents, liable parent or legal guardian (if applicable). Exclusion Criteria: * Has ever received either an extensively hydrolysed infant formula or an AAF prior to enrolment * Has a fever above 38.5°C at enrolment * Has ever experienced a medically diagnosed serious anaphylactic reaction * Use of antibiotic drugs at enrolment. Infants may be enrolled if antibiotics have been stopped at least 7 days prior to enrolment. (Antibiotic treatment can be initiated during the study if an infant develops a condition after enrolment that requires antibiotic treatment). * Infant with a health condition or family situation that makes the infant unsuitable to participate in the trial according to the opinion of the investigator * Infant or infant's carers are unable to comply with trial procedures * Currently participating or has participated in another clinical trial within 4 weeks prior to trial start.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.

Timeframe: baseline, Week 2

Trial details

NCT IDNCT03004729

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01

View on ClinicalTrials.gov More Cow Milk Allergy trials